Back to resultsPrimary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
Primary Purpose
Osteoarthritis, Arthritis, Rheumatoid, Avascular Necrosis of Bone
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Replacement
Total knee replacement
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Replacement
Eligibility Criteria
Inclusion Criteria: Osteoarthritis Rheumatoid arthritis Avascular necrosis (AVN) of bone Other inflammatory arthritis Post-traumatic arthritis Juvenile rheumatoid arthritis Exclusion Criteria: Prior ipsilateral TKA Metabolic disorders Joint replacement due to autoimmune disorders History of recent/active joint sepsis Charcot neuropathy Psycho-social disorders that would limit rehabilitation Greater than 75 years of age at the time of surgery Severe diabetes mellitus Skeletal immaturity
Sites / Locations
- West Coast Orthopaedic Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Rotating Platform Cruciate Retaining Knee implant
Rotating Platform Cruciate Substituting Knee implant.
Outcomes
Primary Outcome Measures
Knee Society scores
Secondary Outcome Measures
Complications
Revisions
Medical imaging
SF-12 patient outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00289081
Brief Title
Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
Official Title
Multi-center Prospective Clinical Evaluation of the P.F.C.® Sigma™ Rotating Platform Knee Primary Cases Cruciate Retaining Versus Cruciate Substituting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Business reasons
Study Start Date
February 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the clinical performance of the cruciate ligament retaining or cruciate ligament substituting implants by obtaining a series of primary TKAs. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Detailed Description
The study will evaluate the clinical performance of cruciate ligament retaining or cruciate ligament substituting implants through a series of primary TKAs. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee implant or the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee implant and assignment will be randomized.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthritis, Rheumatoid, Avascular Necrosis of Bone, Post-traumatic Arthritis, Rheumatoid Arthritis
Keywords
Total Knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
399 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Rotating Platform Cruciate Retaining Knee implant
Arm Title
2
Arm Type
Active Comparator
Arm Description
Rotating Platform Cruciate Substituting Knee implant.
Intervention Type
Device
Intervention Name(s)
Total Knee Replacement
Other Intervention Name(s)
P.F.C.® Sigma™ RP Cruciate Retaining Knee implant
Intervention Description
Rotating Platform (RP) Cruciate Retaining Knee implant
Intervention Type
Device
Intervention Name(s)
Total knee replacement
Other Intervention Name(s)
P.F.C.® Sigma™ RP Cruciate Substituting Knee implant.
Intervention Description
Rotating Platform (RP) Cruciate Substituting Knee implant.
Primary Outcome Measure Information:
Title
Knee Society scores
Time Frame
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary Outcome Measure Information:
Title
Complications
Time Frame
On-going to end of study
Title
Revisions
Time Frame
On-going to end of study
Title
Medical imaging
Time Frame
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Title
SF-12 patient outcomes
Time Frame
Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis
Rheumatoid arthritis
Avascular necrosis (AVN) of bone
Other inflammatory arthritis
Post-traumatic arthritis
Juvenile rheumatoid arthritis
Exclusion Criteria:
Prior ipsilateral TKA
Metabolic disorders
Joint replacement due to autoimmune disorders
History of recent/active joint sepsis
Charcot neuropathy
Psycho-social disorders that would limit rehabilitation
Greater than 75 years of age at the time of surgery
Severe diabetes mellitus
Skeletal immaturity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy L O'Dell, EMT, CCRA
Organizational Affiliation
DePuy Orthopaedics
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
West Coast Orthopaedic Specialists
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Cleveland Heights
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
12. IPD Sharing Statement
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Primary TKA Cruciate Retaining vs Cruciate Substituting With Rotating Platform Knee Prostheses
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